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FDA 510(k)

E1000 Dx Digital Pathology Solution

K-Number: K241717 · 2025-02-28

ApplicantShandon Diagnostics Limited
Decision Date2025-02-28
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

E1000 Dx Digital Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Shandon Diagnostics Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241717. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E1000 Dx Digital Pathology Solution?

E1000 Dx Digital Pathology Solution is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Shandon Diagnostics Limited. The 510(k) number is K241717.

When did E1000 Dx Digital Pathology Solution receive FDA 510(k) clearance?

E1000 Dx Digital Pathology Solution received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241717.

Who is the listed applicant for E1000 Dx Digital Pathology Solution?

The FDA 510(k) record lists Shandon Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E1000 Dx Digital Pathology Solution?

The FDA product code for E1000 Dx Digital Pathology Solution is PSY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07624318TROP2 NMR Concordance StudyNOT_YET_RECRUITING

Related Devices (Code: PSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.K251952VirasightVirasoft CorporationK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.K242783Roche Digital Pathology DxVentana Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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